Oroflocina

PATIENT INFORMATION LEAFLET: USER INFORMATION

Oroflocina, 500 mg, film-coated tablets

Levofloxacin

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you, do not give it to others, as it may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Oroflocina and what is it used for
• 2. Important information before using Oroflocina
• 3. How to use Oroflocina
• 4. Possible side effects
• 5. How to store Oroflocina
• 6. Other information

1. WHAT IS OROFLOCINA AND WHAT IS IT USED FOR

Levofloxacin belongs to a group of antibiotics called fluoroquinolones. It inhibits the growth of bacteria that cause infections.
Oroflocina is used to treat the following bacterial infections:

• sinusitis,
• respiratory tract infections in patients with chronic respiratory disorders (chronic bronchitis),
• pneumonia,
• complicated (difficult to treat) urinary tract infections, including kidney infections (pyelonephritis),
• skin and soft tissue infections, including muscle infections; sometimes called "soft tissue infections",
• prostate infections.

• 2.

IMPORTANT INFORMATION BEFORE USING OROFLOCINA

When not to use Oroflocina

• If the patient has been diagnosed with an allergy (hypersensitivity) to levofloxacin or any of the other ingredients of the medicine or in case of hypersensitivity to other quinolone antibiotics. The list of excipients is provided in section 6.
• If the patient has epilepsy, as the risk of seizures increases.
• If the patient has ever had tendon problems (e.g., tendonitis) while taking fluoroquinolone antibiotics. During levofloxacin treatment, there is an increased risk of similar symptoms, including tendon rupture.
• In pregnant or breastfeeding women. Oroflocina may cause adverse effects in the child (see also "Pregnancy and breastfeeding").
• This medicine is intended for use in adults and should not be given to children or adolescents during growth. It may damage the growth cartilage.

When to exercise special caution when using Oroflocina

• If the patient has a history of brain damage, e.g., stroke or severe head injury, before using Oroflocina, the doctor should be informed, due to the increased risk of seizures.
• The risk of seizures also increases when using Oroflocina with other medicines, such as fenbufen or similar medicines used to reduce rheumatic pain and inflammation, or with theophylline (a medicine used in asthma) (see also "Using Oroflocina with other medicines"). The doctor should be aware of the patient's medical history so that they can provide proper treatment.
• When using Oroflocina, it is recommended to avoid prolonged exposure to strong sunlight. Do not use UV lamps or sunbeds, as Oroflocina may increase sensitivity to light (reactions similar to sunburn).
• If the patient experiences severe diarrhea with blood or mucus during or even several weeks after treatment, they should immediately inform their doctor. This may be a sign of a severe bowel disease (pseudomembranous colitis) and it may be necessary to stop using Oroflocina and start treating the bowel disorder.
• Levofloxacin may (rarely) cause tendonitis (pain and swelling and redness in the tendon area), especially in older people and those treated with corticosteroids (cortisone and similar medicines). If the patient experiences any tendon problems, they should immediately inform their doctor and rest the affected limb to avoid tendon damage. It may be necessary to stop the treatment (see "When not to use Oroflocina").
• If the patient has a rare genetic disorder that affects the functioning of an enzyme called glucose-6-phosphate dehydrogenase (G6-PD), they should inform their doctor. The disease can cause a deficiency of certain chemicals in red blood cells. During levofloxacin treatment, these red blood cells are broken down, leading to anemia and jaundice.
• If the patient has a history of mental disorders, they should inform their doctor, as levofloxacin may cause suicidal thoughts or self-harm attempts. If they occur, the treatment should be stopped immediately.
• If the patient has kidney problems, the dose of Oroflocina may need to be adjusted (see section 3 "How to use Oroflocina").
• If the patient is taking anticoagulant medicines, such as warfarin, they should inform their doctor or nurse, as the concurrent use of these medicines may increase the risk of bleeding (see also "Using Oroflocina with other medicines").
• It is known that levofloxacin may cause severe allergic reactions, even during or after the first dose. If the patient experiences hives or other types of rash, difficulty breathing, or other symptoms of hypersensitivity (see also section 4 "Possible side effects"), they should immediately inform their doctor or nurse.

and other symptoms of hypersensitivity (see also section 4 "Possible side effects"), they should immediately inform their doctor or nurse.

• If the patient has diabetes and is taking insulin or oral anti-diabetic medicines, they should inform their doctor or nurse, as the concurrent use of Oroflocina may lead to hypoglycemia. The doctor should recommend careful monitoring of blood glucose levels.

Caution should be exercised when using this type of medicine if: the patient has a congenital or family history of prolonged QT interval (visible on the ECG - a test of heart electrical activity), the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels), the patient has a very slow heart rate (called bradycardia), the patient has poor heart function (heart failure), the patient has had a heart attack, the patient is a woman or an older person, the patient is taking other medicines that may affect the heart rhythm (see section "Using Oroflocina with other medicines").

• If the patient feels weakness, tingling, numbness of hands, feet, or face, they should immediately tell their doctor or nurse, as it may be necessary to stop the treatment.
• Levofloxacin may cause a false positive result in a urine test for opioids (narcotics). If the patient is to undergo such a test, they should inform their doctor about taking the medicine.
• Levofloxacin may cause liver damage, rarely leading to liver failure (mainly in patients with pre-existing liver disease). If the patient experiences unexplained symptoms such as loss of appetite, yellowing of the skin or eyes, dark urine, itching, or abdominal pain, they should immediately contact their doctor.

Using Oroflocina with other medicines

Tell your doctor or nurse about all the medicines you are currently taking or have recently taken, including those that are available without a prescription. It is especially important to inform about the medicines listed below.

• Fenbufen or similar medicines used to treat rheumatic pain and inflammation or theophylline (a medicine used in respiratory diseases such as asthma). Taking levofloxacin with these medicines increases the risk of seizures.
• Probenecid (used in gout) or cimetidine (used to treat stomach ulcers or heartburn). These medicines reduce the excretion of levofloxacin in the urine.
• Cyclosporine (a medicine that reduces the activity of the immune system, used e.g., after organ transplantation). Levofloxacin prolongs the action of this medicine.
• Anticoagulant medicines, such as warfarin.
• If the patient is taking other medicines that may affect the heart rhythm, such as anti-arrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial medicines (belonging to the macrolide group), or certain antipsychotic medicines, they should inform their doctor.
• Medicines that reduce stomach acid (used to treat heartburn or stomach pain), containing magnesium or aluminum (see also "How to use Oroflocina").
• Sucralfate (a medicine that protects the stomach lining), (see also "How to use Oroflocina").
• Medicines containing iron salts (used to treat anemia), (see also "How to use Oroflocina").

Using Oroflocina with food and drink

Oroflocina can be taken on an empty stomach or during meals. The tablet should be swallowed with water.

Pregnancy and breastfeeding

Oroflocina should not be used during pregnancy or suspected pregnancy or during breastfeeding, as it may harm the child.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

The medicine may cause drowsiness and dizziness and affect vision (see also "Possible side effects"), which may impair the ability to concentrate and prolong the reaction time. If such reactions occur, do not drive vehicles, operate hazardous machinery, or engage in similar activities.

• 3.

HOW TO USE OROFLOCINA

Always use the medicine as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

• Your doctor will tell you how many tablets to take, when, and for how long. This depends on the type and severity of the infection.
• In most cases, one or two tablets are taken once a day. The dose should be taken regularly every 12 hours or every 24 hours.
• The tablets should be swallowed whole or divided, with a glass of water. Do not crush or chew them.
• The tablets can be taken during meals or between meals.
• If the patient is also taking medicines that reduce stomach acid (used to treat heartburn or stomach pain), sucralfate (a medicine that protects the stomach lining), or medicines containing iron salts (used to treat anemia), they should not be taken at the same time as levofloxacin. These medicines should be taken at least 2 hours before or 2 hours after taking Oroflocina. Otherwise, they may reduce its effectiveness.

Adults and older people

• SinusitisOne 500 mg Oroflocina tablet once a day.
• Respiratory tract infections in patients with chronic respiratory disorders (chronic bronchitis)Half a tablet or one 500 mg Oroflocina tablet once a day.
• PneumoniaOne 500 mg Oroflocina tablet once or twice a day.
• Urinary tract infections, including kidney or bladder infectionsHalf a 500 mg Oroflocina tablet per day.
• Skin and soft tissue infections, including muscle infectionsHalf a 500 mg Oroflocina tablet once a day or one 500 mg Oroflocina tablet once or twice a day.
• Prostate infectionsOne 500 mg Oroflocina tablet per day.

Patient with
kidney problems
The doctor will adjust the dose of Oroflocina according to the degree of kidney problems, as smaller doses are used in patients with kidney failure than in those with normal kidney function.
Older patients (with normal kidney function)
No dose adjustment is necessary.
Patient with
liver problems
No dose adjustment is necessary.

Using more than the recommended dose of Oroflocina

If the patient takes more than the recommended dose of Oroflocina, they should immediately contact their doctor or the nearest hospital. Symptoms of overdose include confusion, dizziness, loss of consciousness, seizures, and heart rhythm disturbances. Treatment is symptomatic. Levofloxacin is not removed from the body by dialysis. There is no specific antidote available.

Missing a dose of Oroflocina

If a dose is missed, it should be taken as soon as possible. The next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.

Stopping the use of Oroflocina

It is important to complete the entire treatment cycle prescribed by the doctor. Do not stop it earlier, even if you feel better. If the patient stops taking the tablets too early, their condition may worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Oroflocina can cause side effects, although not everybody gets them.

Immediately inform your doctor or nurse

If you experience any of the following symptoms of a severe allergic reaction:

• swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing,
• severe dizziness or fainting,
• severe or itchy rash, especially if blisters appear on the skin, around the lips, eyes, mouth, nose, or genitals.

These are serious side effects. Emergency medical attention may be required.
They occur very rarely (less than 1 in 10,000 patients) and may appear even after the first dose of Oroflocina.

Other possible side effects

Common(less than 1 in 10 patients):

• nausea, diarrhea,
• increased liver enzyme activity in the blood.

Uncommon(less than 1 in 100 patients):

• loss of appetite,
• indigestion, vomiting, abdominal pain, gas, constipation,
• itching and rash,
• headache and dizziness, drowsiness,
• sleep disturbances, nervousness,
• increased or decreased white blood cell count,
• abnormal laboratory test results for liver or kidney function,
• general weakness,
• fungal infections (and overgrowth of other bacteria resistant to antibiotics).

Rare(less than 1 in 1,000 patients):

• severe diarrhea with stools containing mucus or blood due to colitis (see also "When to exercise special caution when using Oroflocina"),
• tingling of hands and feet, tremors,
• seizures,
• anxiety, depression, psychotic reactions, restlessness, and confusion,
• rapid, irregular heartbeat or palpitations,
• abnormally low blood pressure,
• tendon pain and inflammation (see also "When to exercise special caution when using Oroflocina"),
• joint or muscle pain,
• decreased platelet count, leading to bruising and bleeding,
• decreased neutrophil count in the blood,
• shortness of breath, wheezing,
• hives.

Very rare(less than 1 in 10,000 patients):

• significant decrease in white blood cell count (agranulocytosis), leading to symptoms such as recurring or prolonged fever, sore throat, and malaise,
• fainting due to low blood sugar (hypoglycemia), especially in diabetic patients,
• hallucinations, psychotic reactions with a risk of suicidal thoughts (see also "When to exercise special caution when using Oroflocina"),
• weakness, tingling, and numbness of hands and feet or face (see also "When to exercise special caution when using Oroflocina"),
• taste and smell disorders,
• vision disturbances (blurred vision, double vision),
• hearing disturbances,
• allergic pneumonia, causing shortness of breath, cough, and fever,
• hepatitis,
• tendon rupture (see also "When to exercise special caution when using Oroflocina"),
• muscle weakness, especially important in patients with myasthenia - a rare neurological disorder,
• acute kidney failure, which may result from an allergic reaction (interstitial nephritis),
• abnormally high body temperature.

Frequency not known(cannot be estimated from available data):

• increased sweating,
• decreased count of all blood cell types (pancytopenia),
• decreased red blood cell count, leading to pallor or yellowing of the skin and weakness and shortness of breath (hemolytic anemia),
• ringing or buzzing in the ears,
• very rapid heartbeat, life-threatening irregular heartbeat, heart rhythm disturbance (called "QT interval prolongation", visible on the ECG - a test of heart electrical activity),
• severe liver dysfunction, starting with loss of appetite, yellowing of the skin and eyes (jaundice), dark urine, itching, and abdominal pain (see also "When to exercise special caution when using Oroflocina"),
• severe muscle pain, tenderness, painful weakness, or cramps (rhabdomyolysis),
• finger, hand, chest, or back pain,
• hypersensitivity (allergic reaction).

Other effects observed with fluoroquinolones and may also occur with Oroflocina

• movement disorders, including difficulty moving (extrapyramidal symptoms),
• allergic vasculitis,
• exacerbation of porphyria in patients with porphyria (a very rare metabolic disorder).

Any antibacterial medicine that destroys certain strains of bacteria can lead to an imbalance between microorganisms (bacteria, fungi) that normally occur in humans. As a result, the number of other bacteria or fungi may increase, which in some cases may require treatment.
If any side effect gets worse or if you notice any side effects not listed in the leaflet, tell your doctor.

5. HOW TO STORE OROFLOCINA

Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the carton or blister after the "Expiry date" label. The expiry date refers to the last day of the month.
There are no special storage instructions for Oroflocina.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. OTHER INFORMATION

What Oroflocina contains

• The active substance (active ingredient) is levofloxacin in the form of levofloxacin hemihydrate. Each tablet contains 500 mg of levofloxacin.
• Other ingredients of the medicine are:

tablet core:hypromellose 6cP, microcrystalline cellulose PH 102, sodium stearyl fumarate, crospovidone type A,
tablet coating (Opadry pink):hypromellose 6cP, titanium dioxide (E 171), talc, macrogol 8000, iron oxide red (E 172), iron oxide yellow (E 172).

What Oroflocina looks like and what the pack contains

Oroflocina is a pink, film-coated tablet in the shape of a capsule, approximately 16.0 × 8.0 mm in size, with a dividing line on both sides.
The tablet can be divided into two halves.
The tablets are available in blisters in a cardboard box.
Each box contains 1, 5, 7, 10, 50, 200, or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

JELFA SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Manufacturer

Farmaprojects, S.A.
Santa Eulália 240-242

• 08902 – L’Hospitalet de Llobregat Barcelona Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom

Levofloxacin 500 mg film-coated tablets

Lithuania

OROFLOCINA 500 mg film-coated tablets

Latvia

OROFLOCINA 500 mg coated tablets

Czech Republic

OROFLOCINA 500 mg film-coated tablets

Slovakia

OROFLOCINA 500 mg film-coated tablets

Hungary

OROFLOCINA 500 mg film tablet

Romania

OROFLOCINA 500 mg film-coated tablets

Bulgaria

OROFLOCINA 500 mg филмирани таблетки
Date of leaflet approval: 05-12-2011